FDA approves first test to help screen for risk of opioid use disorder

(CNN) — The US Food and Drug Administration approved a novel tool Tuesday that uses genetic testing to help assess whether certain people are at risk of developing opioid use disorder.

The AutoGenomics AvertD test is meant for adults who are considering a short-term course of oral opioid pain medications, such as after a planned surgical procedure. It can be prescribed only to people who have no prior use of opioids, and patients must consent to the test. It is not meant for those who are being treated for chronic pain.

“The opioid crisis, one of the most profound public health issues facing the United States, calls for innovative measures to prevent, diagnose and treat opioid use disorder, including to assess the risk of developing the disorder,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of those with the disorder and decrease the misuse of opioid analgesics.”

However, some experts are skeptical about its use in clinical practice – and caution that some of its limitations could have dangerous unintended consequences.

The AvertD test uses a sample from a cheek swab to analyze 15 genetic markers that are involved in the brain’s reward pathways and associated with addiction.

But genetics are a “complex trade,” said Dr. Andrew Saxon, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine. “It’s not a simple Mendelian inheritance where one gene has a mutation and that gives you opioid use disorder. It’s a multitude of different genes, all contributing to this effect.”

And there’s evidence that these factors can show up in varying degrees across demographic groups, which can make them hard to identify in population samples, said Dr. Katherine Keyes, a professor at the Columbia University Mailman School of Public Health whose research focuses on psychiatric and substance use epidemiology.

“So the likelihood that a commercially developed genetic test for OUD would have the kind of validity that you would need to really drive clinical practice, based on the broader scientific literature, seems like a stretch,” she said. “If you just ask people, ‘Do you have a family history of addiction?’ I would hypothesize that that would be a better risk categorizer than this genetic test.”

Even asking a patient about their history of substance use, particularly tobacco use, could be just as insightful, Saxon said.

If the genetic test is relied upon too heavily, a false negative result on the test could give patients and their providers an inflated sense of security about their risk of developing opioid use disorder, and a false positive could limit a patient’s access to useful medications.

This risk-benefit analysis was at the heart of a discussion about the test at an FDA advisory committee meeting in October 2022, and the independent panel ultimately recommended against it in an 11-2 vote.

FDA subsequently worked with AutoGenomics as it modified the test. The terms of the new approval require the company to provide training to health care providers in appropriate use of the test and to conduct a large study assessing post-market performance with regular progress reports.

Information from the test “may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,” Shuren said. “This information should be used as part of a complete clinical evaluation and risk assessment; it should not be used alone to make treatment decisions.”

About 6 million people in US ages 12 and older had an opioid use disorder in 2022, according to recent survey data from the US Department of Health and Human Services. And drug overdose deaths have surged in recent years, with opioids involved about three-quarters of the time. More than 83,000 people died from an overdose involving an opioid last year, according to data from the US Centers for Disease Control and Prevention.

“I do still think that prescribed opioids remain a prominent risk factor for the development of opioid use disorder,” Keyes said. “I would just encourage clinicians to look at the literature and make sure that they’re comfortable with the level of safety of the product.”

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